Evaluation of Post-endodontic Pain After Root Canal Treatment With Two Rotary Systems : Mtwo & Safe-sider

NCT ID: NCT02644031

Last Updated: 2015-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Post-endodontic pain (PP) still is major problem for endodontic patients, analgesics are routinely prescribed. Incidence of PP is reported extensively, and reviewed. PP is a complicated multi factorial process and is affected by factors related to patients, to the tooth and to the skills and experience of the dentist and because of that, if the interrelation of these factors is not considered in a PP, study data might be confusing. Any study trying to evaluate the effect of a specific technique or new device in the incidence or characteristics of PP should control all the confounding factors that have been described to be involved in the tested outcome.

reports mention a variable prevalence of PP, ranging from 82.9 to 10.6%. These variations are because of the differences in study methods, and treatment procedures after root canal treatment, selection of patients or experience and skills of the dentists, vary when different studies are compared.

Many studies had confirmed that chemomechanical debridement of the root canal results in extrusion of dentinal chips, pulp tissue fragments, necrotic tissues, microorganisms, and root canal irrigants through the apical foramen. All preparation techniques and instruments, regardless of maintaining shorter working length of the apical terminus have reported to be related with extrusion of infected debris, and some of them extruded less material and others extruded more.

Periapical inflammation and postoperative flare-ups may result from apical extrusion of debris that is also referred to as the "worm" of necrotic debris A common outcome of the studies examining the amount of apically extruded debris was that the techniques involving a push-pull filing motion usually produce a greater mass of apical debris than those have rotational action Files which has reciprocating and in-and-out filing motion, may act as a piston, extruding more debris and irrigants. While the file with continuous rotation motion like a screw conveyor improving transportation of dentinal chips and debris coronally.

In this study, investigators compare post-endodontic pain between these two systems. Mtwo ( continuous rotation system) with safe-sider (reciprocating system). Therefore, the aim of this study is Evaluation of post-endodontic pain after root canal treatment with two rotary systems: Mtwo \& safe-sider

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain, Postoperative

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Instrumentation Post-operative pain Root canal preparation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mtwo rotary system

( continuous rotation system)

Group Type EXPERIMENTAL

mtwo rotary system

Intervention Type PROCEDURE

post-treatment pain after using mtwo rotary system

safe-sider rotary system

(reciprocating system)

Group Type EXPERIMENTAL

safe-sider rotary system

Intervention Type PROCEDURE

post-treatment pain after using safe-sider rotary system

hand files

k-files

Group Type EXPERIMENTAL

hand files

Intervention Type PROCEDURE

post-treatment pain after using hand files

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

mtwo rotary system

post-treatment pain after using mtwo rotary system

Intervention Type PROCEDURE

safe-sider rotary system

post-treatment pain after using safe-sider rotary system

Intervention Type PROCEDURE

hand files

post-treatment pain after using hand files

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age range 20-50 years
* the systemically healthy
* first or second molar teeth require root canal therapy
* irreversible Pulpitis signed without the apical
* root canal curvature of less than 25 degrees, according to Schneider techniques

Exclusion Criteria

* Root canal treatment,
* history of medication (antibiotics, NSAID, opiates) of the patient 12 hours before treatment ,
* pregnancy,
* complex anatomy,
* channels blocked in the x-ray plate,
* internal and external resorption,
* open apex teeth,
* periodontal disease,
* inflammation and abscesses,
* sinus tract,
* presence of radiographic lesions,
* tooth sensitivity to percussion,
* absence of occlusal contact .
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Zahedan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

eshaghali saberi, professor

Role: STUDY_CHAIR

professor of endodontics department

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Zahedan University of Medical Science

Zahedan, Sistan and Baloochestan, Iran

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Iran

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

arezoo hooshmandi, postgraduate

Role: CONTACT

Phone: 00989177089315

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

arezoo hooshmandi, postgraduate

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

7203

Identifier Type: -

Identifier Source: org_study_id